CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 78 enrolled
Drug / intervention
Extraoral anchorage +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00995436
NCT00995436N/ACompleted

Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics

Chesterfield and North Derbyshire Royal Hospital·interventional·Posted Oct 15, 2009·Updated Aug 5, 2016

In Brief

A clinical study evaluating Extraoral anchorage, Miniscrews, and 1 other intervention for Malocclusion and Class II Buccal Segment Relationship. Completed, enrolled 78 participants across 1 site.

Detailed Summary

Research problem: Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use. Aim: To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws. Hypothesis: There is no difference in the amount of anchorage loss between the three methods of anchorage reinforcement. Design: Randomized clinical trial. Setting: District General Hospital orthodontic department Participants: 78 patients requiring "absolute anchorage". Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for anchorage. Method of investigation: The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned to one of three groups of anchorage reinforcement Outcome measures: 1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points 2. Patient perception of the different treatment methods, including surgical experience Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive statistics and uni-variate tests will initially be done to explore the data. Final data analysis will involve the relevant multi-variate statistical modeling. Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 15, 2009
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 16.7 years ago

Interventions

Extraoral anchoragedevice

Extra oral anchorage

Miniscrewsdevice

Intraoral skeletal anchorage using mini screws

Nancedevice

Intraoral dental anchorage by using Nance palatal arch on molars